Establish, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with CAP, ISO15189:2012, and regulatory requirements.
Prepare reports and conduct Management Review Meetings to assess quality and performance.
Coordinate the Corrective and Preventive Action (CAPA) process, managing nonconformities and ensuring timely resolution.
Oversee Internal Quality Assessments, Interim Self-Inspections, and external audits, including CAP and ISO assessments, and customer audits.
Manage the vendor system to ensure effective control and surveillance of critical suppliers of materials and services.
Ensure personnel are properly trained on QMS procedures and maintain accurate training documentation.
Review and resolve complaints and ensure adherence to regulatory requirements.
Monitor test performance and equipment validations, calibrations, and preventive maintenance, ensuring compliance with established performance specifications.
Oversee document change orders, ensuring quality and compliance throughout the process.
Allocate resources, administer laboratory services, and manage budget planning, while providing ongoing education on CLIA compliance.
Qualifications
Minimum of five (5) years of experience related to Quality Assurance or Regulatory Affairs in a regulated industry plus a Bachelor's Degree
-OR-
A minimum of seven (7) years of experience related to Quality Assurance or Regulatory Affairs in a regulated industry.
Strong communication and leadership skills
Ability to investigate and resolve quality problems
Strong auditing knowledge and experience is also required.
Additional Notes:
This is a hybrid position requiring on-site presence for three days a week, with the ability to work remotely two days a week. A remote work policy agreement will be signed by the employee and their manager.